Compliance Series 1: Managing Compliance Risks with EAM

In our previous blog series, we briefly explored the growing enforcement of the FDA. From 2007 to 2012, the number of warning letters given by the FDA drastically increased as the FDA became more aggressive. The focus of this blog series, Managing Compliance Risks with EAM, will take an in-depth look into the trends surrounding FDA inspections in recent years (2013 & 2014) and what to expect from the FDA looking into 2015. We’ll cover recent trends in FDA observations, EAM/CMMS best practices on managing compliance risks, and balancing those risks with investment.

FDA’s Focus from 2012 to 2014

The year 2012 was the last year for a drastic increase in the number of warning letters given by the FDA. In 2013, the FDA’s budget was reduced, which led the agency to conduct fewer inspections. With fewer inspections, the number of warning letters produced by the agency also fell. Furthermore in 2014, the FDA proposed to increase their budget by $821 million in which 94% would be paid through user fees. Despite the proposal to increase the overall budget, the FDA decreased human drug, biologics and medical device programs by $15 million citing that “’these are tight budget times, and the FDA budget request reflects this reality.’”

The FDA’s website provides a snapshot of information on 483s that were issued during 2014. With a reduced budget on the Life Sciences industry, the FDA focused on these significant areas which were frequently cited as observations:

Lack of or inadequate procedures – Procedures for corrective and preventive action have not been [adequately] established. – 21 CFR 820.100(a)

Lack of or inadequate process validation – A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. – 21 CFR 820.75(a)

Written procedures not established/followed – “Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. – 21 CFR 211.67(b)

Procedures not in writing, fully followed – The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. – 21 CFR 120.11(a)(1)(iv)(C)

Records not signed and dated by qualified individual – “Your review of [critical control point monitoring records] [corrective action records] [calibration records] [periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience. – 21 CFR 120.11(a)(1)(iv)

Calibration/Inspection/Checking not done – Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. – 21 CFR 211.68(a)

Instrument calibration – You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine intervals or as necessary] to ensure the accuracy and precision of the instruments or controls. 21 CFR 111.27(b)

A Bigger Budget for the FDA in 2015

In the 2015 Justification of Estimates for Appropriations Committees, FDA Commissioner Margaret Hamburg requested a budget of $4.7 billion, an increase of approximately $400 million from 2014. With the budget increase, the FDA is looking to increase foreign inspections and decrease inspections done in the United States by 40%. However, with fewer domestic inspections planned in 2015, the FDA will rely on a risk-based selection model in which companies that have proven high-quality manufacturing and have a clear history of cGMP violations will be less likely to be inspected.

Cost of Non-Compliance: FDA Warning Letters

As we’ve discussed in previous blogs, it is challenging to quantify the cost of a warning letter from the FDA due to immense number of variables and intangibles associated with it. Life Sciences companies know that the impact and cost to their company from a warning letter or 483 can be quite considerable.

Since it is so difficult to place a value on the cost of non-compliance, Life Sciences companies should turn their focus to understanding the types of observations that can impact their company. In addition, we’ll discuss the role of an EAM/CMMS in balancing compliance risks with investment in the rest of the series.

For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.

Check out the other blogs in our Managing Compliance Risks with EAM/CMMS series: